FDA orphan status to Mesoblast’s rexlemestrocel-L

The FDA has granted Orphan Drug Designation (ODD) to Mesoblast’s (NASDAQ:MESO) rexlemestrocel-L, for prevention of post-implantation mucosal bleeding in end-stage chronic heart failure (CHF) patients who require a left ventricular assist device (LVAD).

Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.

https://seekingalpha.com/news/3473136-fda-grants-odd-mesoblasts-rexlemestrocel-l